U.S. Department of Health and Human Services (HHS) is taking several new actions as part of the Biden-Harris Administration’s commitment to increase access to COVID-19 testing. The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with the Food and Drug Administration (FDA). NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative. This new program will help distinguish manufacturers of high-quality tests and encourage them to bring those tests to the U.S. market, increasing overall supply and potentially lowering costs for people including American Indian/Alaska Natives (AI/AN).
The FDA also authorizes additional over-the-counter rapid antigen COVID-19 test. This agency has granted an emergency use authorization for over-the-counter single-use testing for symptomatic adults and over-the-counter serial testing for all adults. Read more.